Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy.

Females: In females of reproductive potential, this drug may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treatment.

Males: This drug may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings in animals this drug can cause fetal harm when administered to a pregnant woman. In animal reproduction studies it was embryotoxic and abortifacient when given during organogenesis at doses approximately 0.12 times the recommended human dose.

Comments:
-This drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception during and for 6 months after ending therapy.
-This drug may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after ending therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: This drug can harm a nursing infant.

Most experts consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially anthracyclines such as this drug. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence; however, the high levels and persistence of this drug in milk make defining an appropriate abstinence interval difficult. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

See references